Image-guided therapy of a tissue

ABSTRACT

Image-guided therapy of a tissue can utilize magnetic resonance imaging (MRI) or another medical imaging device to guide an instrument within the tissue. A workstation can actuate movement of the instrument, and can actuate energy emission and/or cooling of the instrument to effect treatment to the tissue. The workstation and/or an user of the workstation can be located outside a vicinity of an MRI device or other medical imaging device, and drive means for positioning the instrument can be located within the vicinity of the MRI device or the other medical imaging device. The instrument can be an MRI compatible laser or high-intensity focused ultrasound probe that provides thermal therapy to, e.g., a tissue in a brain of a patient.

RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 14/661,212 filed Mar. 18, 2015, which is related to and claims thebenefit of U.S. Provisional Patent Application 61/955,124 entitled“Image-Guided Therapy of a Tissue” and filed Mar. 18, 2014. The presentdisclosure is also related to U.S. Provisional Patent Application61/955,121 entitled “Image-Guided Therapy of a Tissue” and filed Mar.18, 2014. The contents of each of the above listed applications arehereby incorporated by reference in their entireties.

BACKGROUND

Cancerous brain tumors can be “primary” tumors, meaning that the tumorsoriginate in the brain. Primary tumors include brain tissue with mutatedDNA that grows (sometimes aggressively) and displaces or replaceshealthy brain tissue. Gliomas are one type of primary tumor thatindicate cancer of the glial cells of the brain. While primary tumorscan appear as single masses, they can often be quite large,irregularly-shaped, multi-lobed and/or infiltrated into surroundingbrain tissue.

Primary tumors may not be diagnosed until the patient experiencessymptoms, including those such as headaches, altered behavior, andsensory impairment. However, by the time the symptoms develop, the tumormay already be large and aggressive.

One treatment for cancerous brain tumors is surgery. Surgery involves acraniotomy (i.e., removal of a portion of the skull), dissection, andtotal or partial tumor resection. The objectives of surgery may includeremoving or lessening of the number of active malignant cells within thebrain, or reducing a patient's pain or functional impairment due to theeffect of the tumor on adjacent brain structures. Not only can surgerybe invasive and accompanied by risks, for some tumors, surgery is oftenonly partially effective. In other tumors, surgery may not be feasible.Surgery may risk impairment to the patient, may not be well-tolerated bythe patient, and/or may involve significant costs, recovery time, andrecovery efforts.

Another treatment for cancerous brain tumors is stereotacticradiosurgery (SRS). SRS is a treatment method by which multipleintersecting beams of radiation are directed at the tumor such that, atthe point of intersection of the beams, a lethal dose of radiation isdelivered, while tissue in the path of any single beam remains unharmed.However, confirmation that the tumor has been killed is often notpossible for several months post-treatment. Furthermore, in situationswhere high doses of radiation may be required to kill a tumor, such asin the case of multiple or recurring tumors, it is common for thepatient to reach a toxic threshold for radiation dose, prior to killingall of the tumors. Reaching this toxic threshold renders furtherradiation is inadvisable.

SUMMARY

In one aspect, the present disclosure relates to an apparatus includinga low profile skull anchor device configured to attach to an area of askull of a patient, the low profile skull anchor device including acentral opening for access to an entry formed in the skull of thepatient, where the low profile skull anchor device, upon attachment tothe area of the skull, protrudes from the area of the skull at a heightno greater than forty millimeters. The apparatus may further include aremovable guide stem configured to detachably connect to the low profileskull anchor device, the removable guide stem including a cylindricalopening, where upon connection of the removable guide stem to the lowprofile skull anchor device, the cylindrical opening is positionedsubstantially above the entry formed in the skull of the patient, andthe removable guide stem is configured to adjust a trajectory of thecylindrical opening in at least one of a tilt direction and a rotationdirection.

In some implementations, the low profile skull anchor device includes atleast three fastener positions for attaching the low profile skullanchor device to bone anchors set in the skull of the patient usingscrews. The low profile skull anchor device may include at least threeskull pins for maintaining a gap between the low profile skull anchordevice and a surface of the skull of the patient, thereby avoiding skincompression. The central opening of the low profile skull anchor devicemay be at least sixty millimeters in diameter.

In some implementations, the low profile skull anchor device includes atleast two fastener openings for connecting the removable guide stem tothe low profile skull anchor device. The removable guide stem mayinclude a ball joint for adjusting the trajectory of the cylindricalopening in both the tilt direction and the rotation direction. Theremovable guide stem may include a tilt adjustment mechanism foradjusting the trajectory of the cylindrical opening in a tilt directionand a separate rotation adjustment mechanism for adjusting thetrajectory of the cylindrical opening in a rotation direction. At leastone of the removable guide stem and the low profile skull anchor devicemay include a number of guide lines for aid in setting the trajectory ofthe cylindrical opening.

In some implementations, the apparatus includes a guide sheath, wherethe guide sheath is configured for insertion within the cylindricalopening of the removable guide stem, and the guide sheath includes atleast one hollow lumen extending between a proximal end of the guidesheath and a distal end of the guide sheath, where the at least onehollow lumen is configured for introduction of a neurosurgicalinstrument. The removable guide stem may include a lock mechanism forlocking the guide sheath to the removable guide stem at a selectedlinear depth of insertion within the cylindrical opening of a number oflinear depths of insertion available for selection. The distal end ofthe guide sheath may include two or more openings for deployment of theneurosurgical instrument.

In one aspect, the present disclosure relates to a head fixation systemincluding an upper ring portion including a nose indent for positioningthe nose of a patient when a head of the patient is encircled by thehead fixation system, and a lower ring portion including a number ofsupport posts, where the number of support posts are configured tosupport the head of the patient laid upon the lower ring portion, andthe lower ring portion is configured to lock to the upper ring portionafter positioning the head of the patient upon the number of supportposts.

In some implementations, the support posts are adjustably connected tothe lower ring portion via a number of slots, where the head fixationsystem includes more slots than support posts. Each support post of thenumber of support posts may include at least one connection point forconnecting a fastener. The at least one connection point may beconfigured for connection of a skull pin. Each support post of thenumber of support posts may include at least three connection points forconnecting a fastener, where a positioning of a fastener upon a firstsupport post of the number of support posts is user selectable. Uponpositioning the head of the patient between the lower ring portion andthe upper ring portion and locking the lower ring portion to the upperring portion, a user may tighten the fasteners to fix a position of thehead of the patient.

In some implementations, the head fixation system includes one or moreadditional upper ring portions, where the upper ring portion is selectedbased upon a size of the head of the patient. The lower ring portion maybe curved to provide at least forty degrees of angular head adjustmentupon placing the head fixation system within a fixation ring channel ofa patient table.

In one aspect, the present disclosure relates to a probe for use ineffecting intracranial high intensity focused ultrasound (HIFU)treatment, including at least one ultrasonic transducer, an acousticcoupling medium contacting the at least one ultrasonic transducer, and arigid external shaft for interstitial positioning of the at least oneultrasonic transducer, where the rigid shaft is up to 3.5 millimeters indiameter, and the at least one ultrasonic transducer is mounted withinthe rigid external shaft. The probe may be configured to driveultrasonic energy at least three centimeters into tissue for effectingthermal treatment of the tissue.

In some implementations, the at least one ultrasonic transducer ismounted in a side-firing position within the rigid external shaft. Theat least one ultrasonic transducer may include a linear array of threeor more ultrasonic transducers. The at least one ultrasonic transducermay be a planar transducer. The thermal treatment may include one ofcoagulation and cavitation.

The foregoing general description of the illustrative implementationsand the following detailed description thereof are merely exampleaspects of the teachings of this disclosure, and are not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of an exemplary layout of an MRI Control Room,an MRI Scan Room, and an MRI Equipment Room;

FIG. 2 is an illustration of a perspective view of a patient insertedinto an MRI, with a head fixation and stabilization system installed;

FIG. 3 illustrates a probe driver;

FIGS. 4A and 4B are flow charts illustrating an exemplary procedure fortreating a patient;

FIGS. 5A through 5E illustrate a low profile skull anchoring device andexample guide stems;

FIGS. 5F and 5G illustrate a guide stem and sheath configured tointerconnect with the low profile skull anchoring device;

FIGS. 5H and 5I illustrate example internal configurations of a guidesheath;

FIGS. 6A and 6B illustrate a head fixation system;

FIG. 6C illustrates a locking mechanism;

FIGS. 6D and 6E illustrate a mounting location on an MRI platform forthe head fixation system of FIGS. 6A and 6B;

FIG. 7 is an illustration of an MRI coil holder;

FIG. 8 is an illustration of a pre-shaped probe deployed from a rigidsheath;

FIGS. 9A through 9C illustrate a high intensity focused ultrasoundprobe;

FIGS. 10A and 10B illustrate a method for MR thermal monitoring usingoffset thermal imaging planes; and

FIG. 11 illustrates exemplary hardware of a workstation.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

In the drawings, like reference numerals designate identical orcorresponding parts throughout the several views.

As used herein, the words “a,” “an” and the like generally carry ameaning of “one or more,” unless stated otherwise. The term “plurality”,as used herein, is defined as two or more than two. The term “another”,as used herein, is defined as at least a second or more. The terms“including” and/or “having”, as used herein, are defined as comprising(i.e., open language). The term “program” or “computer program” orsimilar terms, as used herein, is defined as a sequence of instructionsdesigned for execution on a computer system. A “program”, or “computerprogram”, may include a subroutine, a program module, a script, afunction, a procedure, an object method, an object implementation, in anexecutable application, an applet, a servlet, a source code, an objectcode, a shared library/dynamic load library and/or other sequence ofinstructions designed for execution on a computer system.

Reference throughout this document to “one embodiment”, “certainembodiments”, “an embodiment”, “an implementation”, “an example” orsimilar terms means that a particular feature, structure, orcharacteristic described in connection with the example is included inat least one example of the present disclosure. Thus, the appearances ofsuch phrases or in various places throughout this specification are notnecessarily all referring to the same example. Furthermore, theparticular features, structures, or characteristics may be combined inany suitable manner in one or more examples without limitation.

The term “or” as used herein is to be interpreted as an inclusive ormeaning any one or any combination. Therefore, “A, B or C” means “any ofthe following: A; B; C; A and B; A and C; B and C; A, B and C”. Anexception to this definition will occur only when a combination ofelements, functions, steps or acts are in some way inherently mutuallyexclusive.

Further, in individual drawings figures, some components/features shownare drawn to scale to exemplify a particular implementation. For somedrawings, components/features are drawn to scale across separate drawingfigures. However, for other drawings, components/features are shownmagnified with respect to one or more other drawings. Measurements andranges described herein relate to example embodiments and identify avalue or values within a range of 1%, 2%, 3%, 4%, 5%, or, preferably,1.5% of the specified value(s) in various implementations.

The system or method may include one or more processors and circuitsthat embody aspects of various functions by executing correspondingcode, instructions and/or software stored on tangible memories or otherstorage products. A display may include various flat-panel displays,including liquid crystal displays.

The treatment of tumors by heat is referred to as hyperthermia orthermal therapy. Above approximately 57° C., heat energy needs only tobe applied for a short period of time since living tissue is almostimmediately and irreparably damaged and killed, for example through aprocess called coagulation, necrosis, or ablation. Malignant tumors,because of their high vascularization and altered DNA, are moresusceptible to heat-induced damage than healthy tissue. In otherprocedures, heat energy is applied to produce reversible cell damage.Temporary damage to cellular structures may cause the cells to be moreconducive to certain therapies including, in some examples, radiationtherapy and chemotherapy. Different types of energy sources, forexample, laser, microwave, radiofrequency, electric, and ultrasoundsources may be selected for heat treatment based on factors including:the type of tissue that is being treated, the region of the body inwhich the tissue to be treated is located, whether cellular death orreversible cellular damage is desired, the nature of energy applicationparameters for each source, and variability of the energy applicationparameters. Depending on these factors, the energy source may beextracorporeal (i.e., outside the body), extrastitial (i.e., outside thetumor), or interstitial (i.e., inside the tumor).

In interstitial thermal therapy (ITT), a tumor is heated and destroyedfrom within the tumor itself, energy may be applied directly to thetumor instead of requiring an indirect route through surrounding healthytissue. In ITT, energy deposition can be extended throughout the entiretumor. The energy can be applied to heat tissue in the treatment area toa temperature within a range of about 45° to 60° C.

An exemplary ITT process begins by inserting an ultrasound applicatorincluding one or more transducers into the tumor. The ultrasonic energyfrom the applicator may therefore extend into the tissue surrounding theend or tip including the one or more transducers to effect heatingwithin the tumor. In some implementations, the transducer(s) is/arealigned with an edge of the applicator and the applicator is rotatableso as to rotate the ultrasonic energy beam around the axis of theapplicator to effect heating of different parts of the tumor atpositions around the applicator. In other implementations or for otherapplications, the transducer(s) are presented on a tip of the applicatoror otherwise surrounding an inserted portion of the applicator.Depending upon the distribution of transducers, the applicator may bemoved longitudinally and/or rotated to effect heating of the tumor overa full volume of the targeted region.

In yet other implementations, the ultrasonic applicator is controlledand manipulated by a surgeon with little or no guidance apart from thesurgeon's memory of the anatomy of the patient and the location of thetumor. In still other implementations, images may be used during the ITTprocess to provide guidance for treatment. For example, locations oftumors and other lesions to be excised can be determined using amagnetic resonance imaging (MRI) system or computer tomography (CT)imaging system. During the ITT process, for example, MRI imaging can beused in real time to control or aid in guidance accuracy in an automatedor semi-automated fashion.

In some implementations, thermography (e.g., MR thermography, ultrasonicthermography, etc.) provides contemporaneous temperature feedbackregarding one or both of the targeted region and the surrounding tissueduring the ITT process. The temperature information, for example, can beused to monitor necrosis of tumor tissue while ensuring that surrounding(healthy) tissue suffers minimal to no damage. The temperature feedback,in some implementations, is used to perform either or both of:automating engagement of the ultrasonic energy and cooling functionalityof the ultrasonic applicator. In this manner, it is possible to controla temperature distribution or thermal dose in and around the tumor.

Effecting treatment to a tissue, in some implementations, includes anautomated drive mechanism with a holder to hold a treatment device(e.g., medical probe, ultrasonic applicator, laser fiber, etc.). In someimplementations, the drive mechanism is motorless and consists ofthermal imaging compatible components. The drive mechanism, for example,can be configured without an electric motor. The drive mechanism, insome examples, is included in an MRI or MRI head coil. The drivemechanism can be coupled to one or more wires or umbilicals such that atranslation of the one or more wires or umbilicals affects one or moreof a longitudinal displacement of the holder and a rotation of theholder. A controller, in some implementations, processes positioncontrol signals for setting and/or monitoring a position of the holder(e.g., via an input interface to the wires or umbilicals), and issuessubsequent position control signals to manipulate positioning of theholder (e.g., via an output interface to the wires or umbilicals).

The system or method, in some implementations, includes a guidemechanism that is attachable to a surface of a patient. The guidemechanism, for example, can include a base structure configured toremain stationary relative to the patient when the guide mechanism isattached to the surface of the patient in a locked state. The guidemechanism can further include a tilt portion that is coupled to the basestructure and provides an adjustable tilt between a trajectory of thedrive mechanism and the base structure. The guide mechanism can furtherinclude a rotation portion that provides an adjustable rotation of thetilt portion relative to the base structure.

The controller, in some implementations, is configured to process asequence of the position control signals to direct the guide mechanismto move the holder during treatment. For example, the controller can beprogrammed to move the holder to a first position for effecting thetreatment to the tissue at a first portion of the tissue that coincideswith the first position and then move the holder to a second positionfor effecting the treatment to the tissue at a second portion of thetissue that coincides with the second position.

During treatment, in some implementations, a workstation transmits theposition control signals to the controller and displays feedback images(e.g., MRI images and/or thermometry images) of the tissue to a user ofthe workstation. The workstation, for example, can continuously displaythe thermometry images of the tissue during the treatment to the tissueat the first and second portions of the tissue, and while the holdermoves between the first and second positions.

In some implementations, an imaging system receives images of the tissueand the treatment device and analyzes the images to monitor control ofpositioning and/or therapeutic energy delivery within the tissue. Forexample, the imaging system may process, in real time, the images of thetissue and the treatment device, as well as the thermometry images ofthe tissue to forecast errors or interruptions in the treatment to thetissue. Responsive to the analysis, the imaging system may display, viathe workstation, an appropriate warning. Position control signals may beupdated and transmitted by the workstation to the controller based onone or more of the images, as the images are received by the workstationin real time.

In some implementations, treatment is delivered via an energy emissionprobe, such as an ultrasonic applicator or laser probe. The energyemission probe, in some examples, may include one or more emitters, suchas a radiofrequency emitter, HIFU emitter, a microwave emitter, acryogenic cooling device, and a photodynamic therapy light emitter. Theenergy emission probe may include multiple emitters, where the emittersare longitudinally spaced with respect to a longitudinal axis of theenergy emission probe.

In some implementations, the energy emission of the probe can becontrolled to generate a number of different energy output patterns. Thedifferent patterns, for example, can include energy delivered via two ormore ultrasonic transducers and/or two or more laser fibers. Forexample, a laser probe may include a first laser fiber for outputting asymmetrical output pattern with respect to a longitudinal axis of thefirst laser fiber and a second laser fiber for outputting anasymmetrical output pattern with respect to a longitudinal axis of thesecond laser fiber. In another example, an ultrasonic applicator mayinclude a first ultrasonic transducer for outputting a first ultrasonicfrequency and a second ultrasonic transducer for outputting a secondultrasonic frequency.

The energy output pattern, in some implementations, includes a pulsedoutput pattern. For example, a higher power density may be achievedwithout causing tissue scorching or carbonization by pulsing a highpower laser treatment for x seconds with y seconds break between so thattissue in the immediate vicinity of the treatment area has anopportunity to dissipate. In a particular example, the laser pattern maybe active for two seconds and inactive for one second.

In some implementations, the treatment pattern includes effectingtreatment while simultaneously moving the probe (e.g., linearly and/orrotationally). For example, an ultrasonic probe may be rotated while anemission pattern is simultaneously adjusted to effect treatment at adesired depth based upon a particular geometry of a region of interest(ROI) including a targeted tissue area. In one embodiment, the ROTincludes multiple targeted tissue areas, which are treated eitherconcurrently, consecutively, or in succession. In this manner, forexample, while the ultrasonic treatment beam is focused upon a radialportion of the tumor having a depth of 1.5 centimeters, the powerdensity of the HIFU probe may be tuned for this first treatment depth.Upon rotation to a second radial portion of the tumor may have a depthof 2 centimeters, the power density of the HIFU probe may be increasedaccordingly to tune for this second treatment depth of 2 centimeters.

An energy source generates energy for the probe. In someimplementations, the workstation transmits energy control signals to theenergy source. The workstation, for example, may be configured toprocess a sequence of the energy control signals to first effect asymmetrical treatment area with respect to the tissue, via the probe,and subsequently effect an asymmetrical treatment area with respect tothe tissue, via the probe, after the symmetrical treatment. In aparticular example, the workstation may be configured to process asequence of position and laser control signals to move the holder to afirst position for effecting the treatment to the tissue at a firstportion of the tissue that coincides with the first position, effect asymmetrical treatment to the first portion of the tissue with the firstlaser fiber, move the holder to a second position for effecting thetreatment to the tissue at a second portion of the tissue that coincideswith the second position, and effect an asymmetrical treatment to thesecond portion of the tissue with the second laser fiber. Duringtreatment, the workstation may be configured to display thermometryimages of the tissue continuously and concurrently with processingcontrol signals specifying the position and energy associated with thesymmetrical and asymmetrical treatments.

In some implementations, the system or method includes a guide sheathconfigured to accept two or more probes associated with different energymodalities as the treatment device. The modalities may include, forexample, laser, radiofrequency, HIFU, microwave, cryogenic, photodynamictherapy, chemical release and drug release. The guide sheath may includeone or more off-axis lumens for positioning an emitting point of one ormore of the number of probes at an off-axis angle.

A system in accordance with this disclosure incorporates, in anembodiment, MRI-compatible energy emission probes and/or other treatmentdevices and accessories for controlled delivery of thermal therapy to anumber of locations and tumor sizes within a brain. The system, however,is not limited to MRI-guided thermal therapy, as other therapies such ascomputer tomography (CT) are utilized in other embodiments. Further,this disclosure refers to an MRI scanner as an exemplary medical imagingmachine, which may be referred to herein as an MRI.

I. Overview

Turning to FIG. 1, in certain embodiments, an environment 100 forintracranial therapy includes an interface platform 102 (herein aninterface platform or interface console), a system electronics rack 104and components (herein rack), and a control workstation 106 (hereinworkstation). The interface platform 102 may be used to manipulate andmonitor therapy equipment related to one or more energy sources, such asprobe introduction equipment including, in an embodiment, a probedriver, a probe, and/or a probe holding and alignment device. The probeintroduction equipment, in some examples, can include the low profileanchoring system described in FIGS. 5A-5G below or the stereotacticminiframe described in U.S. patent application Ser. No. 13/838,310 toTyc, filed Mar. 14, 2013 and titled “Image-Guided Therapy of a Tissue,”incorporated herein by reference in its entirety. In certainembodiments, the workstation 106 is configured to control the interfaceplatform 102 for control of the energy emission therapy equipment.

The interface platform 102 is secured to a patient table 108 of an MRIsystem 110. The MRI system 110 may include a head coil and stabilizationsystem (herein stabilization system), an instrument adaptor, and an MRItrajectory wand. Exemplary MRI systems that can be utilized togetherwith the features discussed herein include those manufactured by SiemensAG, Munich, Germany (including the MAGNETOM AVANTO, TRIO, ESPREE, VERIOMRI Systems, which are trademarks and/or trade names of Siemens AG).Further, example MRI systems include those manufactured by GeneralElectric Company, Fairfield, Conn. (including the SIGNA, OPTIMA andDISCOVERY MRI systems, which are trademarks and/or trade names ofGeneral Electric Company).

In certain embodiments, all of the above components of the interfaceplatform 102 and the energy emission therapy equipment are MRIcompatible, which refers to a capability or limited capability of acomponent to be used in an MRI environment. For example, an MRIcompatible component operates and does not significantly interfere withthe accuracy of temperature feedback provided by the MRI systemoperating with exemplary flux densities including: magnetic fluxdensities of 1.5 T or 3.0 T, where no hazards are known for a specifiedenvironment (e.g., 1.5 T or 3.0 T). Compatibility can also be definedwith respect to one or more other magnetic flux densities, including atleast 0.5 T, 0.75 T, 1.0 T, 2 T, and 5 T.

In certain embodiments, the system electronics rack 104 includes cables,penetration panels and hardware that effectuate mechanical, electrical,and electronic operation of the energy emission therapy equipment andthe MRI system 110. The system electronics rack 104 may further be usedto power and route control signals and/or communications for the controlworkstation 106.

The workstation 106 includes a display that displays a user interface,e.g., a graphical user interface (GUI) and/or a command line interfacethat enables a user to plan a treatment procedure and interactivelymonitor the procedure, the interface platform 102, and the entire MRIsystem 110. In certain embodiments, the user interface also provides theuser, e.g., a medical professional, the ability to directly control theenergy emission therapy equipment including an energy source associatedtherewith, and therefore, enables directly control of the application ofthe therapy to the patient.

Turning to FIG. 2, an exemplary position of a patient on the patienttable 108 of the MRI system 110 is illustrated. The interface platform102 is secured to the patient table 108 together with a head coil 202and stabilization system, which is a head fixation device thatimmobilizes a patient's head. The stabilization system includes a headfixation ring 204. A probe 206 and probe driver 208 are coupled to probeintroduction equipment 210, and to the interface platform 102 viaumbilicals. A cable, for example, can be used to provide data, laser,fluid, etc. connections between the probe 206, probe driver 208, andinterface platform 102 and the electronics rack 104 in the MRI equipmentroom (as illustrated in FIG. 1).

The probe introduction equipment 210, in certain embodiments, includesat least a portion that is detectable by the MRI system (e.g., includedin temperature data that is displayed by an imaging portion of the MRIsystem) and is used for trajectory determination, alignment, andguidance of the probe 206. An MRI trajectory wand (e.g., an MRIdetectable, fluid-filled tube) may be placed into the probe introductionequipment 210, for example, to confirm a trajectory, associated with anintended alignment, to a targeted tissue region, via MRI. Afterconfirmation, the probe 206 may be introduced into the probeintroduction equipment 210 to effect surgery or therapy.

The probe 206 may be composed of MRI compatible materials that permitconcurrent energy emission and thermal imaging, and can be provided inmultiple lengths, cross-sectional areas, and dimensions. Types of probesthat can be utilized with the components and procedures discussed hereininclude RF, HIFU, microwave, cryogenic, and chemical release probes; thechemical release probes may include photodynamic therapy (PDT), and drugreleasing probes. Treatments in accordance with the descriptionsprovided in this disclosure include treatments that ablate (i.e.,“treat”) a tissue to destroy, inhibit, and/or stop one or more or allbiological functions of the tissue, or otherwise cause cell damage orcell death that is indicated by a structural change in cells of thetargeted tissue area. Ablation can be effected by laser, RF, HIFU,microwave, cryogenic, PDT and drug or chemical release. A correspondingprobe and/or other instrument, such as a needle, fiber or intravenousline can be utilized to deliver one or more of these ablation agentsintracorporeally or percutaneously and proximate to, in the vicinity of,abutting, or adjacent to a targeted tissue area so as to effecttreatment. The probe 206 can be a gas-cooled probe so as to controldelivery of the energy to the targeted tissue area. The length anddiameter of the probe 206 is preselectable based on the targeted tissuearea and/or the ROI. The probe 206, in some particular examples, can bea laser delivery probe that is used to deliver laser interstitialthermal therapy or a HIFU applicator that is used to deliver HIFUinterstitial thermal therapy.

The probe driver 208 controls positioning, stabilization andmanipulation of the probe 206 within a specified degree of precision orgranularity. Turning to FIG. 3, the components of the probe driver 208generally include a commander 302, umbilicals 304, a follower 306, and aposition feedback plug 308 that receives position feedback signals from,for example, potentiometers within the follower 306. The probe 206(illustrated in FIG. 2) can be inserted into the follower 306, and thefollower 306 can control a rotational and longitudinal alignment and/ormovement of the probe 206. The probe driver 208 can further include arotary test tool (not illustrated) that can be used during a self-testprocedure to simulate attaching a probe to the follower 306. Anexemplary probe driver that can be utilized in accordance with thevarious aspects presented in this disclosure is described in U.S. Pat.No. 8,728,092 to Qureshi, entitled “Stereotactic Drive System” and filedAug. 13, 2009, the entirety of which is incorporated herein byreference.

The probe driver 208 (illustrated in FIG. 2) is mounted to the interfaceplatform 102. The position feedback plug 308 (illustrated in FIG. 3)connects to the interface platform 102 in order to communicate theposition of the probe 206 to the user and/or the workstation 106(illustrated in FIG. 1). The probe driver 208 is used to rotate ortranslate, e.g., by extending or retracting the probe 206. The probedriver 208, in a particular example, can provide, at a minimum, atranslation of 20-80 mm, 30-70 mm, 40-60 mm or 40 mm, with a maximumtranslation of 60 mm, 80 mm, 100 mm, 120 mm or 60-150 mm. The probedriver 208, further to the example, can also provide, at a minimum, arotation of 300°-340°, with a maximum rotation of 350°, 359°, 360°,540°, 720° or angles therebetween.

Returning to FIG. 1, in certain embodiments, the workstation 106 outputssignals to the MRI system 110 to initiate certain imaging tasks. Inother implementations, the workstation 106 outputs signals to anintermediary system or device that causes the MRI system 110 to initiatethe imaging tasks. In certain embodiments, the workstation 106additionally outputs signals to the electronics rack 104. Theelectronics rack 104 includes various actuators and controllers thatcontrol the thermal therapy devices, such as, in some examples, acooling fluid pressure and/or a flow rate of the cooling fluid, and apower source that powers a thermal therapy device. In one example of athermal therapy device, the power source is a laser source that outputslaser light via an optical fiber. As illustrated in FIG. 1, theelectronics rack 104 is located in an MRI Equipment Room and includesstorage tanks to hold the cooling fluid, one or more interfaces thatreceive the signals from the control workstation 106 and/or a separateMRI workstation, an energy emission source (e.g. laser), and an outputinterface. One or more of the interfaces are connected with or includephysical wiring or cabling that receives the signals and transmits othersignals, as well as physical wiring or cabling that transmit energy tocorresponding components in the MRI Scan Room through a portal thatroutes the signals and/or energy in a manner that minimizes anyinterface with or by the MRI system 110. The wiring or cabling areconnected at or by the interface platform 102 to correspondingcomponents to effect and actuate control of a thermal therapy deviceand/or an associated thermal therapy session. Controlling the thermaltherapy device, for example, by a user in the MRI control room preventsthe introduction of noise to the MRI system, which includes the MRIcabin. The remotely controlled procedure enhances thermal therapyefficiency and accuracy by preventing heating loss due to stopping andrestarting energy application.

In certain embodiments, the system is indicated for use to ablate,necrotize, carbonize, and/or coagulate the targeted tissue area (e.g.,an area of soft tissue) through interstitial irradiation or thermaltherapy, in accordance with neurosurgical principles, with a HIFUthermal therapy device. The HIFU thermal therapy device or probeincludes ultrasonic transducers for directing ultrasonic energy at thetargeted tissue area, causing the tissue to heat. The ultrasonic beam ofthe HIFU probe can be geometrically focused (e.g., using a curvedultrasonic transducer or lens) or electronically focused (e.g., throughadjustment of relative phases of the individual elements within an arrayof ultrasonic transducers). In an ultrasonic transducer array, thefocused beam can be directed at particular locations, allowing treatmentof multiple locations of an ROI without mechanical manipulation of theprobe. The depth of treatment can be controlled by adjusting the powerand/or frequency of the one or more transducers of the HIFU probe.

In certain embodiments, either additionally or alternatively to HIFUthermal therapy, a laser-based thermal therapy is utilized in the MRIsystem. Laser probes of a variety of outputs can be utilized, including,in some examples, laser probes emitting laser light having wavelengthsof 0.1 nm to 1 mm, and laser probes emitting laser light in one or moreof the ultraviolet, visible, near-infrared, mid-infrared, andfar-infrared spectrums. Types of lasers used with respect the laserprobe include, for example, gas lasers, chemical lasers, dye lasers,metal-vapor lasers, solid-state lasers, semiconductor lasers, and freeelectron lasers. In a particular example, one or more wavelengths of thelaser light emitted by the laser probe are within the visible spectrum,and one or more wavelengths of the laser probe are within thenear-infrared spectrum.

In certain embodiments, the environment 100 can be utilized for planningand monitoring thermal therapies effected via MRI-imaging, and canprovide MRI-based trajectory planning for the stereotactic placement ofan MRI compatible (conditional) probe. The environment 100, in certainembodiments provides real-time thermographic analysis of selected MRIimages and thus, temperature feedback information and/or thermal doseprofiles for the targeted tissue area. For example, thermographicanalysis of the MRI images can provide real-time verification ofcellular damage in a targeted tissue area that corresponds to necrosis,carbonization, ablation, and/or coagulation. In another example,thermographic analysis can be used to monitor tissue surrounding aperiphery of an ROI to ensure minimal if any damage to healthy tissues.Components of the environment 100 may assist in guiding, planning,adjusting, performing and confirming a thermal therapy session andtrajectories associated therewith.

A procedure includes, generally, identifying an ROI and/or associatedtargeted tissue areas in a patient that should be treated, planning oneor more trajectories for treating the tissue, preparing the patient andcomponents for the treatment, and performing the treatment. Aspects ofthe various parts of the treatment are described throughout thisdisclosure, and an exemplary sequence of treatment steps is illustratedin FIGS. 4A and 4B.

Turning to FIG. 4A, a process flow diagram illustrates an exemplarymethod 400 for pre-planning a treatment of a patient. In pre-planningthe thermal therapy session, in certain embodiments, pre-treatmentDigital Imaging and Communications in Medicine (DICOM) image data isloaded and co-registered, for example, via the workstation 106(illustrated in FIG. 1). Using the DICOM image data, one or more ROIsand/or targeted tissue areas and one or more initial trajectories can bedetermined and set (402).

In preparation for treatment, in certain embodiments, a head coil andfixation system is attached to the patient (404), for example bypositioning the head coil and stabilization system on the surgicaltable. The patient can be immobilized using a head fixation ring. Toensure stable imaging, for example, the patient's head can be securedwith the head fixation ring and remain fixed for the entire imagingportion of the flow chart in FIG. 4A. An example head fixation system isdescribed below in relation to FIGS. 6A through 6E.

Prior to applying thermal energy to an ROI, a probe entry location intothe skull is identified. In certain embodiments, a burr hole is drilledin the skull (406). The burr hole may be drilled prior to attachment ofprobe introduction equipment (e.g., a miniframe, anchoring device, guidestem, instrument sheath, etc.). A twist-drill hole, in certainembodiments, can be created following a trajectory alignment of theprobe introduction equipment. The twist-drill hole can have a size of1-5 mm, 2 mm, 3 mm, 4 mm or 4.5 mm.

The probe introduction equipment, such as a stereotactic miniframe orlow profile anchoring device, in certain embodiments, is attached to thepatient's head (408). Probe aligning equipment, such as the miniframe orguide stem, can then be aligned along the intended trajectory, forexample using image-guided navigation. After attaching the probeintroduction equipment, the head coil can be attached. An exemplary headcoil system is described below in relation to FIG. 7. Depending on aprocess flow that is specific to a surgical center, the interfaceplatform may be attached prior to or after MRI trajectory confirmation.The order of steps in a site-specific process may be determined based onmembers of MRI or surgical support team and may be determined duringon-site training with respect to the MRI system. The interface platform(IP) is attached to the head end of the head coil and stabilizationsystem. Then, the 1P power and motor plugs are connected.

In certain embodiments, the patient is positioned in the MRI cabin, andMRI imaging is performed to confirm a trajectory (410) associated with athermal therapy device and/or probe introduction equipment. For example,an MRI trajectory wand may be inserted into the probe introductionequipment for use in confirming its trajectory. The trajectory of theprobe introduction equipment, for example, can be evaluated using MRIimaging prior to inserting a probe into the brain. Volumetric imaging orvolumetric visualization may be captured to include the entire head andfull extent of the probe introduction equipment. Along with trajectoryconfirmation, in some examples, beam fiducial marker detection may alsobe performed. For example, the captured images may also display aposition of a beam fiducial marker located in a portion of the probeintroduction equipment. This marker can be detected and identified bythe MRI imaging system and method to store an orientation of thephysical direction of the probe. The captured images, in implementationswhere pre-treatment image data is not available, can be used forplanning a thermal therapy session.

In certain embodiments, a probe actuation and guidance device (e.g., afollower) and a test tool are attached to the probe introductionequipment, to provide positional feedback for a self-test function(412). The self-test function, for example, may be used to confirm thatinputs to the probe actuation and guidance device, (e.g., from theworkstation), accurately and/or precisely drive the probe. Uponcompleting the self-test function, the rotary test tool may be removed.Upon completing the procedure described in relation to FIG. 4A, theprocedure equipment may be introduced and the procedure initiated.

Turning to FIG. 4B, a process flow diagram illustrates an exemplarymethod 420 for a treatment procedure. In certain embodiments, a probe isattached and inserted into the probe introduction equipment and/or thepatient's skull (e.g., secured for manipulation via the probe actuationand guidance device) (422). Exemplary implementations of neurosurgicalprobes are discussed in below under the section entitled “Probes.” It isnoted that different types of probes can be used in conjunctiondifferent types of thermal therapy, for example, when an ROI is not inthe brain. An MRI scan can then be conducted to ensure probe alignmentis correct and confirm movement and delivery of the probe along theintended trajectory. In one example, the acquired image data can bedisplayed, along with pre-planning image data by the workstation 106.Using a graphical user interface (GUI), a user can adjust the probedisplayed by the GUI by interacting with, for example, the GUI to matchthe probe artifact on the acquired image to ensure that the alignmentand arrangement of the probe as physically placed in the probeintroduction equipment and inserted into the patient coincides with therendered probe at the workstation. The probe's trajectory, for example,can be adjusted to a desired position for delivering thermal energy, viainteraction with the GUI. Further, the probe's rotational position canalso be adjusted to a desired direction or angle for thermal delivery,via interaction with the GUI. Once the probe rendering presented by theGUI matches the probe artifact on the display, the user may confirm thetrajectory via the GUI.

In certain embodiments, one or more scan planes are selected for cuing athermal monitoring sequence via the MRI system's sequence protocol list(424). In another embodiment, a 3D volume is selected and in yet anotherembodiment, a linear contour is selected. Parameters associated withscan plane, in some examples, can be entered by a user via a workstationconnected with the MRI system or directly into the thermal monitoringsequences protocol's geometry parameters of the MRI.

In certain embodiments, temperature feedback information and/or thermaldose profiles are initialized and monitored (426). For example, under anoise masking heading of the workstation interface, at least threereference points (e.g., six, twelve, twenty, etc.) can be selected bythe user at the periphery of the ROI. The ROI, for example, may includean overlaid, orange noise mask in one or more image monitoring viewpanes to illustrate the intended thermal delivery area. The noisemasking may be used to improve accuracy of temperature monitoring duringtissue treatment.

In certain embodiments, energy delivery via the probe is actuated tobegin the thermal therapy session (428). For example, once “Ready”indicator or the like is displayed under a laser status heading of theGUI at the workstation, the user may depress a foot pedal operativelyconnected to the workstation to deliver thermal energy to the ROI or atargeted tissue area within the ROT. Thermal energy can then be eithercontinuously or intermittently delivered while monitoring thermal doseprofiles, which can be presented as contours that are overlaid onto oneor more (e.g., three) thermal monitoring view panes rendered by the GUIof the work station. Thermal delivery may be halted as desired or asnecessary by releasing the foot pedal. The view panes, for example, maydisplay an energy dose profile or thermal dose profile supplied by theprobe, with respect to a specified time period and/or a specifiedtargeted tissue area or ROI; the thermal dose or energy dose profile canbe displayed as a succession of temperature gradients. The thermal doseprofiles and/or the temperature gradients permit the determination of anextent of cellular damage in the targeted tissue area and/or othereffects upon the targeted tissue area occurring as a result of thethermal therapy.

Once a thermal dose for a particular alignment and positioning of theprobe is completed, if further probe alignments are desired within thetreatment plan (430), a rotational and/or linear alignment of the probemay be adjusted (432) by translating or rotating the probe. For example,an energy output of the probe may be terminated and then the probe maybe subjected to linear translation and/or rotational movement, which canbe controlled, for example, by a probe driver (a particularimplementation of which is illustrated in FIG. 3). After adjusting theprobe alignment, in certain embodiments, the process returns to step 422to verify a current placement of the probe. In certain embodiments, asecond thermal treatment procedure is not initiated (e.g., whenrepeating step 428) until one or more targeted tissue areas within theROI returns to a baseline body temperature. The thermal dose associatedwith the one or more targeted tissue areas in the ROI, as described inrelation to steps 422 through 432, may continue at various proberotational and/or linear alignments until the entire ROI has beentreated.

Upon determining that the thermal therapy is complete (430), shouldtreatment with an additional probe be needed or desired (434), theprocedure can be repeated by attaching the new probe to the probeintroduction equipment and verifying probe placement (422). If, instead,the second probe was initially included within the probe introductionequipment (e.g., via a separate lumen in a guide sheath in relation tothe first probe), the user may initiate positioning of the second probe,for example, via the GUI, and verify placement of the second probe(422). A multi-probe configuration is described in greater detail inrelation to FIG. 5I.

If the second probe is being deployed to treat the same ROT or the sametargeted tissue area at the same linear and rotational alignment(s)associated with the first probe, in certain embodiments, step 424involving selection of scan planes for the cuing the thermal monitoringsequence may be skipped. If, instead, a second probe is deployed at adifferent linear position or a different trajectory, step 422 may beperformed to confirm the trajectory and alignment of the second probe.

When the thermal therapy is complete (434), in certain embodiments, thepatient is removed from the MRI bore and the probe, probe actuation andguidance device, and probe introduction equipment are detached from thepatient. The bore hole may be closed, for example, at this time.

II. Low Profile Probe Introduction Equipment

A. Low Profile Skull Anchoring Device

In certain embodiments, when preparing for an intracranial neurosurgicalprocedure, a patient 502 is fitted with a low profile skull anchoringdevice 504, as illustrated in an exemplary mounting illustration 500 ofFIG. 5A. The low profile skull anchoring device 504 may be releasablyattached to the head of the patient 502, for example, using three ormore bone anchors mounted to the skull of the patient 502. Turning toFIG. 5B, the low profile skull anchoring device 504 includes three bonescrews 508 for connecting to bone anchors within the skull of thepatient 502, as well as pins 510 for further securing the low profileskull anchoring device 504 to the head of the patient 502 and forensuring that the low profile skull anchoring device 504 mounts abovethe surface of the head of the patient 502. In this way, there will beminimal or no compression of the patient's scalp, and frameless,on-trajectory access is provide, as discussed in further detail below.In one embodiment, the low profile skull anchoring device 504 has anoval or an oblong shape.

In one embodiment, the screws 508 and pins 510 are composed of, forexample, titanium. It should be noted that the screws 508 and the pins510 are not necessarily limited to three pins; the number of screws 508and pins 510 is the number which is necessary to provide sufficientrigidity. The screws 508 and pins 510 may be evenly spaced around thecircumference of the low profile skull anchoring device 504 (e.g.,positioned approximately every 120 degrees). In another embodiment, thescrews 508 and pins 510 are positioned at unequal distances apart, forexample, based on an irregular skull curvature. In yet anotherembodiment, the screws 508 and the pins 510 are movable with respect tothe low profile skull anchoring device 504. In still another embodiment,the screws 508 are replaced with a sufficiently rigid adhesive or astaple, each of which provide sufficient rigidity to allow for thedrilling of a burr hole in the skull.

Due to the low height of the low profile skull anchoring device 504, themedical team is provided with greater access for lateral trajectories ofbiopsy, probes, and other apparatus to be inserted intracranially intothe patient 502 via the low profile skull anchoring device 504. This maybe especially useful when working within the confines of an MRI bore,for example during MRI-guided thermal therapy treatments. As such, thelow profile skull anchoring device 504 may be composed of MRI compatiblematerials and, optionally, include MRI visible markers for aligning adesired trajectory or defining a particular direction relative to thelow profile skull anchoring device 504. In another example, the lowprofile skull anchoring device 504 may allow easier access toback-of-the-head entry trajectories, such as trajectories used inperforming epilepsy treatments. A mounting height of the low profileskull anchoring device 504, for example, may be thirty millimeters orless from the surface of the skull of the patient 502.

In some implementations, the low profile skull anchoring device 504includes one or more fiducial markers for reference within an MRI scan.For example, the low profile skull anchoring device 504 may include atleast three fiducial markers used, in an MRI scan, to identify aposition and orientation of the low profile skull anchoring device 504as attached to the surface of the skull of the patient 502. In aparticular example, three fiducial markers, at least one of which havinga unique length, width, and/or shape in comparison to the others, may bepositioned upon the low profile skull anchoring device 504 to allow forvisual display and confirmation of a position and orientation of the lowprofile skull anchoring device 504 as attached to the skull of thepatient 502. The fiducial marker(s) may be held in place via anysuitable connector including, but not limited to, an adhesive or thelike.

B. Removable Guide Stem

Turning to FIG. 5A, the low profile skull anchoring device 504 includesa removable guide stem 506. The removable guide stem 506, in someexamples, may lock to the low profile skull anchoring device 504 using ascrew mechanism, keyed locking mechanism, or other connector configuredto firmly connect the removable guide stem 502 to the low profile skullanchoring device 504 with relative ease of removal.

Turning to FIG. 5B, the exemplary the low profile skull anchoring device504 includes three connection points 512 for securing the removableguide stem 506 to the low profile skull anchoring device 504. Theremovable guide stem 506, for example, may include a series of guidestem connectors 514 (e.g., screws or locking pins) which mate with theconnection points 512 of the low profile skull anchoring device 504, asshown in FIGS. 5A and 5C. In one embodiment, the alignment of the guidestem connectors 514 and the connection points 512 differs based on askull curvature of the patient.

A central cylindrical portion of the removable guide stem 506 isconfigured to receive various adapters and/or instruments such as, insome examples, drill bits, biopsy needles, and treatment probes. Thecentral cylindrical portion of the removable guide stem 506, in certainembodiments, is rotatably adjustable, allowing an orientation of centralcylindrical portion of the removable guide stem 506 to be manipulated toalign the probe in accordance with a desired trajectory. Upon alignment,in certain embodiments, a locking mechanism 516 may be actuated to lockthe central cylindrical portion of removable guide stem 506 into placeat the set alignment.

Turning to FIG. 5C, the removable guide stem 506 may include, forexample, a ball joint 518 for establishing an adjustable trajectory forpassing instruments to the skull of the patient 502 via the centralcylindrical portion of removable guide stem 506. In certain embodiments,the central portion has another geometric or polygonal shape thatcorresponds to a cross-section of the probe. In certain embodiments,interior portions of the central cylindrical portion of the removableguide stem 506 are deformable so as to cover an outer surface of theprobe. In still other embodiments, the interior portions of the centralcylindrical guide stem are comprised of shape memory alloys that have atransition temperature that exceeds a maximum temperature associatedwith a specified thermal therapy.

The ball joint 518 can achieve a number of trajectories that is based onthe granularity with which the ball joint 518 is manipulated. Uponsetting the trajectory of the central cylindrical portion of removableguide stem 506, for example, the ball joint 518 may be clamped intoposition using the locking mechanism 516. In one embodiment, the lockingmechanism 516 is a cam lock. In another embodiment, the lockingmechanism 516 is a ring clamp. In still another embodiment, the lockingmechanism 516 has a screw engagement.

Turning to FIGS. 5D and 5E, illustrative examples of a removable guidestem 520 including both a tilt adjustment 522 and a rotation adjustment524 are shown. The separate tilt adjustment 522 and rotation adjustment524, for example, may be used to more precisely adjust a trajectory ofthe central cylindrical portion of removable guide stem 520. Uponadjusting the tilt adjustment 522, for example, a tilt lock mechanism526 (e.g., screw, pin and slot, etc.) may be activated to hold thecentral cylindrical portion of removable guide stem 520 at the tiltposition. In another example, upon adjusting the rotation of the centralcylindrical portion of removable guide stem 520, for example by turningthe rotation adjustment 524, a rotation lock mechanism 528 (e.g., screw,pin and slot, etc.) may be activated to hold the removable guide stem520 at the selected rotation. In an embodiment, either or both of thetilt lock mechanism 526 and the rotation lock mechanism 528 are actuatedby a motor. In another embodiment, the motor is wirelessly controlledvia a remotely located controller. The removable guide stem 520 isremovable during a thermal therapy session, prior to completion of thetreatment, and independent of removing the low profile skull anchoringdevice 504.

In certain embodiments, guide lines such as a set of guide lines 530 aremarked on the removable guide stem 520 (or the removable guide stem 506illustrated in FIG. 5A) to provide a user with an indication of theselected trajectory. For example, an angle of tilt in relation to thelow profile skull anchor 504 may be selected via the guide lines 530(e.g., within a one, two, or five degree angle of adjustment). The guidelines 530, in certain embodiments, are MR indicators, such that an MRimage captured of the removable guide stem 520 will allow a softwarepackage to register an initial trajectory in relation to the head of thepatient (e.g., patient 502 of FIG. 5A).

In certain embodiments, in addition to a tilt and rotation adjustment,either the first removable guide stem 506 or the second removable guidestem 520 may be modified to include an x,y degree of freedom adjustmentmechanism (not illustrated). In this manner, a position of the centralcylindrical portion of guide stem 506 in relation to a burr hole openingbeneath the low profile skull anchor 504 may be adjusted by the user,thus providing on-trajectory access. Rather than the central cylindricalportion of guide stem 506 or 520 being centered within the low profileskull anchor 504, for example, an x,y adjustment mechanism may allow anoffset of the central cylindrical portion of removable guide stem 506 or520. In a particular example, should the burr hole fail to be centeredbetween bone anchors planted within the skull of the patient 502, thecentral cylindrical portion of guide stem 506 or 520 may be adjusted byup to at least ten to twenty millimeters to be centered above the burrhole using an x,y adjustment mechanism.

In some implementations, the removable guide stem 506 or 520 includes atleast one fiducial marker for identifying, via an MRI scan, at least anangle of trajectory of the removable guide stem 506 or 520. If theremovable guide stem 506 or 520 additionally includes an adjustmentmechanism, fiducial marker(s) may be used to identify the x,y offset ofthe removable guide stem 506 or 520 relative to the low profileanchoring device 504.

Turning to FIG. 5B, upon removal of the removable guide stem 506 or 520,the skull entry location becomes accessible, for example to allow forformation of a burr hole or to otherwise prepare the skull entrylocation. After preparation of the entrance, the removable guide stem506 or 520 may be locked to the low profile skull anchor 504. Forexample, as illustrated in FIG. 5D, the removable guide stem 520 may belocked to the low profile skull anchor device 504 by attaching screws atthree connection locations 532. At any point in a procedure, shouldaccess to the entrance be desired, the guide stem 520 may be removed.Removal of the guide stem 520, for example, allows a medicalprofessional quick access to react to bleeding or to adjust the burrhole opening for trajectory correction.

When performing a medical procedure via the low profile skull anchoringdevice 504, in certain embodiments, the low profile skull anchoringdevice 504 may first be aligned with screw anchors mounted upon thepatient's skull and then screwed to the head of the patient 502, asillustrated in FIG. 5A. The skull entry location may be prepared fortreatment during the thermal therapy while the removable guide stem 506or 520 has been separated from the low profile skull anchoring device504. Following preparation of the skull entry location, the removableguide stem 506 or 520 may be replaced and its trajectory aligned.

To align the removable guide stem 506, 520 with a desired treatmenttrajectory, in certain embodiments, the removable guide stem 506, 520 ismanipulated via an image guided system (e.g., MRI-imaging system) ormanipulated via a trajectory planning module of an MRI-imaging method.The manipulations of the removable guide stem 506, 520, for example, maybe performed by a probe actuation and guidance device. In a particularexample, as described in relation to the method 400 of FIG. 4A, a testtool may be inserted into the removable guide stem 506, 520, and thetest tool may be aligned with pre-treatment image data to determine aninitial trajectory. In other implementations, a user manually adjuststhe trajectory of the removable guide stem 506, 520. Alignment of thetrajectory of the removable guide stem 506, 520, in certain embodiments,is aided by one or more guide lines or fiducial markers upon the surfaceof the low profile skull anchoring device 504 and/or upon the surface ofthe removable guide stem 506, 520, such as the guide lines 530illustrated in FIG. 5D.

Upon positioning the trajectory of the removable guide stem 506, 520, incertain embodiments, the trajectory is locked via a locking mechanism,such as the locking mechanism 516 of FIG. 5C or the locking mechanisms526 and 528 of FIG. 5D.

After the removable guide stem 502 has been locked into its initialtrajectory, in certain embodiments, instruments may be guided into theskull via the removable guide stem 506 or 520. For example, biopsytools, a thermal treatment probe, medicament delivery probe, or otherneurosurgical device may be delivered to a ROI of the brain of thepatient via the removable guide stem 506 or 520.

C. Guide Sheath

Turning to FIGS. 5F and 5G, in certain embodiments, rather thaninserting instruments directly into the removable guide stem 506 or 520,a guide sheath 540 is inserted into the removable guide stem (e.g.,removable guide stem 506). The guide sheath 540 may include, forexample, one or more distal openings and one or more proximal openingsto introduce at least one neurosurgical instrument to the ROI in thepatient's brain.

In certain embodiments, instead of using the guide sheath 540 configuredfor receipt of neurosurgical devices, a hollow trocar may be introducedvia the removable guide stem 506 or 520 to prepare an initial entry intoa region of the brain. For example, when entering a particularly fibrousarea, rather than pushing in directly with a neurosurgical instrumentand risking damage to the neurosurgical instrument, a trocar orstylette, for example with a bullet shaped nose and sharp distalopening, may be used to cut a path for the neurosurgical instrument. Inother implementations, a stylette or trocar may be introduced to the ROIvia the guide sheath 540. In one embodiment, the guide sheath 540 has ashape of a 3D almond. In another embodiment, a ball joint portion of theguide sheath 540 rotates around a track. In yet another embodiment, theprobe holder is attached at a non-zero angle to the longitudinal accessof at least a portion of the probe.

In certain embodiments, the guide sheath 540 locks to the removableguide stem 506. The guide sheath 540, for example, may be configured tolock to the removable guide stem 506 at a variable linear heightdepending upon a distance between the skull opening and a ROI. In thismanner, the guide sheath 540 may be deployed in proximity to, in thevicinity of, or adjacent to an ROI without abutting or entering the ROI.As such, upon removal of one or more neurosurgical instruments via theguide sheath 540, cells from the ROT will not be able to contaminateother regions of the patient's brain.

Turning back to FIG. 5C, in certain embodiments, a guide stem lockingmechanism 519 may be used to clamp the guide sheath 540 at a particularlinear depth. The guide sheath 540, in a particular example, may havespaced indentations or other connection points for interfacing with theguide stem locking mechanism 519 (e.g., set screw or spring-loadedplunger). The indentations (or, alternatively, ratcheting teeth) may bepositioned at precise measurements (e.g., 1 mm apart) to aid in linearposition adjustment. In other examples, the guide sheath 540 and guidestem locking mechanism 519 may be configured to provide positivefeedback to a medical professional during adjustment. For example, alinear actuator system such as a rack and pinion may be used to provideprecise linear position adjustment (e.g., one “click” per millimeter).Upon adjustment, to lock the guide sheath 540 at the selected linearposition, in certain embodiments a cam lock mechanism may be used toengage teeth or depressions within the guide sheath 540. For example, acam lock mechanism such as the locking mechanism 516 illustrated in FIG.5C may be used to lock the guide sheath 540 at a selected linear depth.

Turning back to FIG. 5D, the removable guide stem 520 similarly includesa guide stem locking mechanism 534. In other implementations, the guidesheath 540 may directly connect to the low profile skull anchoringdevice 504 or to another receiving port connected to the low profileskull anchoring device 504 (not illustrated).

The guide sheath 540, upon interlocking with the guide stem 506, 520and/or the low profile skull anchoring device 504 and receiving one ormore neurosurgical tools, may create an air-tight seal during aneurosurgical operation. For example, the proximal and/or distal end ofthe guide sheath 540 may include a receiving port adaptable to thesurgical instrument being introduced. In certain embodiments, variousguide sheaths can be used interchangeably with the guide stem 506, 520,such that a guide sheath corresponding to the surgical instrumentdiameter may be selected. In other implementations, one or more guidesleeves (not illustrated) may be secured inside the guide sheath 540,each of the one or more guide sleeves having a different distal enddiameter. A divided (e.g., bifurcated) guide sleeve, in certainembodiments, may be used to introduce two or more instrumentssimultaneously or concurrently, each with a particular instrumentdiameter.

In certain embodiments, the guide sheath 540 is intracranially deliveredusing an introducer and guide wire. An image guidance system, such asthe MRI imaging system, may be used instead of or in addition to theintroducer and guide wire during placement of the guide sheath 540. Theguide sheath 540 may be composed of MRI compatible materials.

The materials of the guide sheath 540, in certain embodiments, areselected to provide rigid or inflexible support during introduction ofone or more neurosurgical tools within the guide sheath 540. Forexample, the guide sheath 540 may be composed of one or more of Kevlar,carbon fiber, ceramic, polymer-based materials, or other MRI-compatiblematerials. The geometry of the guide sheath 540, in certain embodiments,further enhances the strength and rigidity of the guide sheath 540.

In certain embodiments, the guide sheath 540 (or guide sleeve, asdescribed above) includes two or more lumens for introduction of variousneurosurgical instruments. By introducing two or more neurosurgicalinstruments via the guide sheath 540, a series of treatments may beperformed without interruption of the meninges layer between treatments.For example, FIG. 5I illustrates two neurosurgical instruments 552 and554 that are simultaneously inserted into a guide sheath 550 and can beused to carry out treatment of a tissue consecutively, concurrently, orsimultaneously.

Neurosurgical instruments deployed via the guide sheath 540 may exit asame distal opening or different distal openings. In certainembodiments, the guide sheath 540 may include at least one off-axisdistal opening. For example, as illustrated in FIG. 5H, exemplary guidesheath 550 includes a contact surface 556 having a predefined angle.Upon encountering the contact surface 556, the trajectory of a surgicalinstrument 552 presented through the guide sheath 550 may be deflectedto exit the proximal end via an off-axis delivery hole 558, asillustrated in FIG. 5I. The angles shown in FIGS. 5H and 5I can beconsidered as drawn to scale in one implementation. However, thealignment of the contact surface 556 and the delivery hole 558 can bevaried by adjusting their respective axial angles. By adjusting theseangles, a number of possible positions of the surgical instrument 554are provided. Further, multiple off-axis delivery holes and multiplecontact surfaces can be provided, which are displaced from each other ina direction of the longitudinal axis of the guide sheath.

Upon introducing a neurosurgical instrument such as a probe, in certainembodiments, the guide sheath 510 enables coupling between the probe anda probe actuation and guidance device. For example, commands for linearand/or rotational control of the probe may be issued to the probe via aninterface within the guide sheath 540.

III. Probes

A number of different probes can be utilized in accordance with thevarious aspects presented in this disclosure. Example probes aredescribed in: U.S. Pat. No. 8,256,430 to Torchia, entitled “HyperthermiaTreatment and Probe Therefor” and filed Dec. 17, 2007; U.S. Pat. No.7,691,100 to Torchia, entitled “Hyperthermia Treatment and ProbeTherefor” and filed Aug. 25, 2006; U.S. Pat. No. 7,344,529 to Torchia,entitled “Hyperthermia Treatment and Probe Therefor” and filed Nov. 5,2003; U.S. Pat. No. 7,167,741 to Torchia, entitled “HyperthermiaTreatment and Probe Therefor” and filed Dec. 14, 2001; PCT/CA01/00905,entitled “MRI Guided Hyperthermia Surgery” and filed Jun. 15, 2001,published as WO 2001/095821; and U.S. patent application Ser. No.13/838,310, entitled “Image-Guided Therapy of a Tissue” and filed Mar.15, 2013. These documents are incorporated herein by reference in theirentireties.

A number of probe lengths are provided in any of the probe examplesdescribed herein based on a degree of longitudinal travel allowed by afollower and a depth of the tissue to be treated. An appropriate probelength can be determined by the interface platform and/or theworkstation during a planning stage, or determined during a trajectoryplanning stage.

Exemplary probe lengths can be indicated on the probes with reference toa probe shaft color, in which white can indicate “extra short” having aruler reading of 113 mm, yellow can indicate “short” having a rulerreading of 134 mm, green can indicate “medium” having a ruler reading of155 mm, blue can indicate “long” having a ruler reading of 176 mm, anddark gray can indicate “extra long” having a ruler reading of 197 mm.Different model numberings can also be utilized on the probes toindicate different lengths.

An energy output pattern of a probe, such as a laser probe or HIFUprobe, in certain embodiments, includes a pulsed output pattern. Forexample, a higher power density may be achieved without causing tissuescorching by pulsing a high power laser treatment for x seconds with yseconds break between (e.g., allowing for tissue in the immediatevicinity to cool down). In a particular example, the energy outputpattern of a probe may include a ten Watt output for two secondsfollowed by a one second period of inactivity. In certain embodiments, aparticular energy output pattern may be developed based upon the type ofprobe (e.g., laser, HIFU, etc.), an emission style of the probe tip(e.g., side-firing, diffuse tip, etc.), and/or the depth of the ROI orthe targeted tissue area (e.g., based in part on the shape of a tumorregion, etc.).

In certain embodiments, a treatment pattern includes effecting treatmentwhile concurrently or simultaneously moving the probe (e.g., linearlyand/or rotationally). For example, a HIFU probe may be automaticallyrotated (e.g., using a commander and follower as described in FIG. 3,etc.) while an emission pattern is simultaneously or concurrentlyadjusted to effect treatment to a desired depth based upon a particulargeometry of the ROI. In this manner, for example, while the ultrasonicprobe's beam is focused on a radial portion of the tumor having a depthof 1.5 centimeters, the power density of the HIFU probe may be tuned forthe first treatment depth. Upon rotation, a second radial portion of thetumor may have a depth of 2 centimeters, and the power density of theHIFU probe may be increased accordingly to tune for the treatment depthof 2 centimeters.

A. Side-Fire HIFU Probe

Turning to FIG. 9A, a view 900 of an exemplary treatment scenarioinvolving a HIFU probe 902 deployed to treat an ROI 906 is illustrated.HIFU technology advantageously provides directional control and greaterdepth penetration as compared with laser-based thermal therapy. Forexample, in comparison to laser therapy, ultrasonic therapy may achieveat least three to four times greater depth penetration. For example,estimated depths of thermal treatment using HIFU technology includethree to five centimeters or greater than six centimeters. By completingtreatment via an initial trajectory, the treatment may be performedfaster and less invasively than it may have been performed using a laserprobe. As such, a HIFU probe may be used to treat a larger ROI withoutthe need to adjust a probe trajectory or introduce the probe intomultiple locations within the brain. Although treatment may be providedat a greater depth, it also may be provided using a narrow focal beam,containing a width of the treated tissue. Furthermore, althoughHIFU-based thermal therapy can advantageously achieve a greaterpenetration depth than laser-based thermal therapy, the ultrasonictreatment has greater uniformity over temperature gradients thanlaser-based thermal therapy, which heats a portion of the targetedtissue area close to the probe much more rapidly than portions of thetargeted tissue area further away from the probe. In selecting thermaltherapy via a HIFU probe, scorching or carbonization of the targetedtissue area close to the probe may be avoided and/or the HIFU probe maybe operated independently of external cooling to protect immediatelysurrounding tissue.

In performing thermal therapy using a HIFU probe, constructive anddestructive interference can be utilized by selecting a number ofdifferent longitudinal spaced emission points to fine tune a positionand depth of energy applied to a targeted tissue area and/or an ROI. Assuch, the depth of energy, as such, may be tuned to conform with anon-uniform, irregular, and/or non-polygonal shape of the ROI which, forexample, corresponds to a tumor. Preparing trajectories, determininglinear translational adjustments and/or rotational movements, and/orenergy output patterns may be selected and/or optimized to preventheating of the skull and/or bouncing energy off of the surfaces of theskull. HIFU treatment, in some examples, can be used for opening ablood-brain barrier, coagulation of tissue, or cavitation of tissue.

The HIFU probe 902 includes one or more side-firing transducers 904 foreffecting treatment to the ROI 906. The ultrasonic transducer(s) 904 maybe flat or rounded. The HIFU probe, in some examples, can include ashaft composed of plastic, brass, titanium, ceramic, polymer-basedmaterials, or other MRI-compatible materials in which one or moreultrasonic transducer(s) 904 have been mounted. The ultrasonictransducer(s) 904 may be mounted upon an interior surface of the shaftof the HIFU probe 902. The ultrasonic transducer(s) 904 may include alinear array of individually controllable transducers, such that afrequency or power output of each transducer 904 may be individuallytuned to control a treatment beam of the HIFU probe 902. For example, asillustrated in FIG. 9C, the tip of the probe 902 can include a lineararray of three transducers 904. The longitudinally spaced aparttransducers 904 can be spaced equally apart. However, in otherimplementations, the spacing between the transducers 904 can be unequal.

In certain embodiments, the HIFU probe 902 includes a cooling mechanismfor cooling the ultrasonic transducers 904. For example, a cooling fluidor gas may be delivered to the tip of the HIFU probe 902 to control atemperature of the ultrasonic transducer(s) 904. Additionally, theultrasonic transducer(s) 904 may be surrounded by an acoustic medium,such as an acoustic coupling fluid (e.g., water) to enable ultrasonicfrequency tuning of the ultrasonic transducer(s) 904.

As illustrated in FIG. 9A, the HIFU probe 902 is embedded within an ROI906 spanning multiple MR thermal monitoring planes 908. Duringtreatment, thermal effects within each MR thermal monitoring plane 908may be monitored in order to monitor thermal coagulation of the ROI 906.Information derived from the thermal monitoring, for example, may be fedback into control algorithms of the HIFU probe 902, for example, toadjust a power intensity and/or frequency of the HIFU probe to tune adepth of treatment of the ultrasonic beam or to adjust a rotationaland/or linear positioning of the HIFU probe 902 upon determining thatablation is achieved at a current rotational and linear position.

To increase the monitoring region, additional MR thermal monitoringplanes 908 may be monitored (e.g., between four and eight planes, up totwelve planes, etc.). Alternatively, in certain embodiments, the threethermal monitoring planes 908 may be spread out over the y-axis suchthat a first gap exists between plane 908 a and plane 908 b and a secondgap exists between plane 908 b and plane 908 c. The thermal monitoringalgorithm, in this circumstance, can interpolate data between the MRthermal monitoring planes 908.

In other implementations, rather than obtaining parallel images of MRthermal monitoring planes, at least three thermal monitoring planes,each at a distinct imaging angle bisecting an axis defined by aneurosurgical instrument such as a thermal ablation probe, may beinterpolated to obtain thermal data regarding a three-dimensionalregion.

Turning to FIG. 10A, an aspect illustration 1000 demonstrates three MRthermal monitoring planes 1002 for monitoring ablation of an ROI 1004 bya probe 1006. The angles between the thermal monitoring planes, in someexamples, may be based upon an anatomy of the region of the skull of thepatient or a shape of the ROI. The angles, in some examples, may differby at least ten degrees.

Turning to FIG. 10B, an end view 1010 of the probe 1006 provides anillustrative example of MR thermal monitoring planes 1002 that are eachoffset by sixty degrees. In comparison to using parallel MR thermalmonitoring planes, the thermal monitoring planes 1002 provide a morerealistic three-dimensional space. Thus, volumetric visualization isprovided. In certain embodiments, volumetric visualization thatindependent of ablation is provided. Temperature gradients and/orthermal dose profiles between the thermal monitoring planes 1002 can beinterpolated. Similar to increasing a number of parallel MR thermalmonitoring planes, in other implementations, four or more thermalmonitoring planes may be captured and combined, for example, to increasethermal monitoring accuracy.

As a result of the side-firing capability of the HIFU probe 902, anumber of rotationally different portions of the ROI can be treated withthe ultrasonic energy by rotating the HIFU probe 902. For example, asillustrated in an x-axis sectional view 910, the HIFU probe 902 may berotated is illustrated in an arrow 912 to effect treatment throughoutthe ROI 906. Additionally, the HIFU probe 902 can be longitudinallytranslated, for example automatically by a follower of a probe driver,to change a longitudinal position at which ultrasonic energy is appliedwithin the ROI 906.

Rotation, power intensity, duty cycle, longitudinal positioning, andcooling, in certain embodiments, are controlled by the electronics rack104 and the workstation 106, such as the electronics rack 104 andworkstation 106 described in relation to FIG. 1. A sequence, such as analgorithm or software encoding, can be executed to cause a probe tip ora number of probe tips to execute a particular energy output patterneffect a predefined thermal therapy to a targeted tissue area. Theenergy output pattern can be based on rotational and/or longitudinalmovements of the probe.

B. Pre-Shaped Probe

Turning to FIG. 8, in certain embodiments, a probe delivery apparatus800 includes a pre-shaped probe 802 (e.g., laser probe) that accesses anROI 806 along a curved path. The pre-shaped probe 802 can be providedproximate to the ROI 806 through a rigid sheath 804 or guide cannula.Although the rigid sheath 804 is straight, the pre-shaped probe 802 isflexible such that it exits the rigid sheath 804 in a predetermined arc.The curvature of the pre-shaped probe 802, for example, can beconfigured to deploy towards a known radial position, for example in aquarter arc of a circle. In exiting the rigid sheath 804, the pre-shapedprobe 802 follows a clean arc along a path into the ROI 806. In thismanner, the pre-shaped probe 802 avoids tearing tissue, for example dueto pushing a distal end of the probe against the targeted tissue areaand/or an ROI.

In certain embodiments, the pre-shaped probe 802 includes a wire and/orpolymer encasement for a laser fiber. The materials of the pre-shapedprobe 802, for example, may prevent the laser probe (and optical fibercorresponding thereto) from straightening, which is its naturalinclination. The pre-shaped probe 802, in certain embodiments, iscomposed of MRI-compatible materials to enable use in MRI-guidedneurosurgery. In one example, the pre-shaped probe may include a polymertubing with a pre-curved band to the probe tip, surrounding a laserfiber. In certain embodiments, a tip region of the pre-shaped probe 802includes at least one fiducial marker to aid in validating an angle ofdeployment from the rigid sheath 804.

During thermal therapy, the pre-shaped probe 802, in certainembodiments, may be deployed into the ROI 806 at a first location, thenwithdrawn into the rigid sheath 804, rotated, and deployed into the ROI806 at a different radial location. A range outline 808 demonstrates arotational range of the pre-shaped probe 802 at a current linearposition. Rotational adjustment of the pre-shaped probe 802 may berepeated a number of times, for example to effect treatment spanningsubstantially a full rotational range 808. Additionally, uponwithdrawal, the rigid sheath 804 may be made linearly adjusted (e.g.,manually or automatically using a probe driver) and the pre-shaped probe802 deployed in a different linear region at the same or a differentrotational projection.

In some examples, a length of the rigid sheath 804 can be approximatelytwelve to fifteen centimeters, and a diameter of the rigid sheath 804can be approximately three-tenths of a centimeter to one centimeter. Adiameter of the pre-shaped probe 802 can be one-tenth of a millimeter tothree millimeters. A curved extension of the pre-shaped probe, forexample, may be about one to two centimeters. The pre-shaped probe 802can include one or more energy delivery elements. For example, thepre-shaped probe may include a diffuse laser emission tip. In certainembodiments, the pre-shaped probe 802 includes a cooling element.Examples of energy element and cooling element configurations of laserprobes are illustrated, for example, in U.S. patent application Ser. No.13/838,310 to Tyc, filed Mar. 14, 2013 and titled “Image-Guided Therapyof a Tissue,” incorporated herein by reference in its entirety.

In certain embodiments, additional neurosurgical instruments may beprovided to the ROI 806 via the rigid sheath 804 along with thepre-shaped probe 802. For example, the pre-shaped probe 802 may bepositioned within the rigid sheath 804 along with other probes to beused consecutively, contemporaneously, simultaneously or concurrentlywith the pre-shaped probe 802.

IV. Head Coil and Stabilization

Prior to positioning in an MRI bore, a head fixation ring is attached tothe patient's head to ensure a fixed position during the thermaltherapy. A standard fixation ring can be problematic, both in fittingvarious sizes of patients and in the difficulty of positioning thepatient within the ring. For example, patients with spinal deformationor unusually large heads (e.g., due to steroid treatments) may bedifficult to position within the standard fixation ring, which ispre-formed.

Turning to FIG. 6A, rather than using a standard size fixation ring forfixating a patient's head, a head fixation system 600 includes an upperring portion 602 and a lower ring portion 604. A patient's head may belaid upon the lower ring portion 604, and the upper ring portion 602 maybe lowered and connected to the lower ring portion 604 such that thepatient's nose is aligned with an indent 606 of the upper ring portion602.

In certain embodiments, the upper ring portion 602 connects with thelower ring portion 604 in an adjustable fashion, providing for a secureand close fit for a variety of head sizes. In other embodiments, varioussizes of upper ring portions 602 may be provided, such that, rather thanconnecting to form a circular ring, each upper ring portion extends toform an ovoid shape of the head fixation system 600 to a differentlength.

As illustrated in FIG. 6A, the lower ring portion 604 includes a numberof support posts 608 for aiding in fixation of the head. The supportposts 608, in certain embodiments, are selectively positioned in anumber of support post mounting slots 610 arranged radially along boththe upper ring portion 602 and the lower ring portion 604. Asillustrated, there are six support post mounting slots 610 arranged onthe upper ring 602 and seven support post mounting slots 610 arranged onthe lower ring 604. In other implementations (not illustrated), thesupport posts 608 are mounted in fixed positions upon one or both of theupper ring portion 602 and the lower ring portion 604. The number ofsupport post mounting slots 610 may vary. Additionally, in anotherembodiment, the support posts 608 may selectively mount by two or morepegs or posts connected to each support post 608 rather than by a singleconnection point (e.g., support post mounting slot 610).

The support posts 608 can be used to introduce a number of fasteners,such as a set of skull pins 612 a and 612 b, for affixing the ringportions 602, 604 to the head of the patient. As illustrated, eachsupport post 608 includes a series of four pin mounts for mounting askull pin 612. In another example, each support post 608 may include anumber of offset pin mounts (not illustrated), such that the pin mountswill not necessarily be centered upon the support post. In this manner,the medical professional may adjust both radial pinning locations viathe support post mounting slots 610 and linear pinning locations via thepin mounts of each support post 608 to adaptably secure a patient withinthe head fixation system 600. In other implementations, rather thanusing pins, a passive fixation system can provide conforming abutments,such as formable pads, for closely securing the head of the patientwithin the head fixation system 600 without the use of pins 612. Theconforming abutments, in one embodiment, are fixedly mounted to eachsupport post 608. In other embodiments, the conforming abutments may bereleasably connected in a manner similar to the fixation pins 612.

A patient's head can be positioned into the lower ring portion 604 andonto skull pins 612. The lower ring portion 604, for example, may bemounted within a channel 622 of a ring mount 624 of a platform 620, asillustrated in FIGS. 6D and 6E. The upper ring portion 602 may then belowered into place, connecting with the lower ring portion 604 (e.g., atmating points 616 and 618). The mating points 616 and 618, in certainembodiments, include spaced indentations or openings for interfacingwith a locking mechanism such as a set screw or spring-loaded plunger.In other implementations, the head fixation system 600 may have spacedratcheting teeth on one of the ring portions 602, 604 for interfacingwith a ball plunger or toggle release mounted on the other ring portion602, 604. In further implementations, a linear actuator system such as arack and pinion may be used to provide position adjustment (e.g., one“click” per linear setting), lockable, for example, using a cam lock.

Positions of the support posts 608 and/or skull pins of the upper ringportion 602 may be adjusted. When a desired positioning has beenachieved, the upper ring portion 602 may be locked to the lower ringportion 604, as illustrated in FIG. 6B.

Turning to FIG. 6C, in a particular example, a locking mechanism 614demonstrates that the upper ring portion 602 may lock to the lower ringportion 604 using keyed shapes secured with a fastener, such as a thumbscrew. After locking the upper ring portion 602 to the lower ringportion 604, the skull pins can be tightened to achieve appropriatefixation. At this point, in certain embodiments, the patient can bewheeled upon the platform 620 to an MRI room, where users can utilizethe handles 626 to move the fixated patient from, e.g., a wheeledoperating table to an MRI table. In other implementations, the platformis part of the MRI table, for example as illustrated in FIG. 2. Thefixation system 600 may be locked to the ring mount 624 via knobs 628.

In certain embodiments, upon positioning the head fixation system 600into the ring mount 624, an angle of the head of the patient can beadjusted. For example, turning to FIG. 6D, the head fixation system 600(not illustrated) may be rotated within the channel 622 (e.g., up tofifty degrees to either the left or the right) prior to locking the headfixation system 600 into the ring mount 624 via the knobs 628.

The head fixation system 600, in certain embodiments, includes one ormore fiducial markers used, for example, to identify a position or typeof head fixation ring. For example, if the upper ring portion 602 is oneof a set of various radiuses of upper ring portions, one or morefiducial markers may identify the particular upper ring portion 602selected. In another example, one or more fiducial markers can be usedto identify an angle of rotation of the head fixation system 600 from acentral position (e.g., nose indent 606 pointing upwards. The fiducialmarkers, in a particular example, may be arranged radially upon anexterior of at least one of the upper ring portion 602 and the lowerring portion 604) for aiding in registration of an MR image.Furthermore, the fiducial markers may be used by a software tool toprovide modeling for the head fixation system 600 in relation to aninstrument introduction apparatus, neurosurgical instruments, and/orother medical equipment used during the neurosurgical procedure. Thefiducial markers, for example, may provide the software with anindication of angle of rotation of the head of the patient.

After attaching the head fixation system 600 to the patient, a head coilcan be fixed to the head fixation system 600 and/or a head coil support630. For example, turning to FIG. 2, a patient is arranged on a patienttable 108 in a bore of the MRI system 110. The patient's head 210 isfixed to a head fixation ring 204 by fixation pins. The head fixationring 204 is received in a ring mount of the patient table 108, forexample the ring mount 624 illustrated in FIG. 6E. The patient table 108extends, in a direction away from the bore of the MRI system 110,providing a head coil support.

Turning to FIG. 7, a head coil system 700 including a coil holder 702that accommodates various off-the-shelf MRI coils, such as an MRI coil704 is illustrated. The coil holder 702, for example, can includeadjustable attachment points for attaching the MRI coil 704 to the coilholder 702. The adjustable attachment points, for example, can includemated fastener openings 708, 710 between a cover 706 and the coil 704.The cover 706, for example, may align over the MRI coil 704 such thatfastener openings 708 in the cover 706 align with fastener openings 710within the coil 704 to hold the coil 704 in place against the coilholder 702. The MRI coil 704 may be aligned with openings in the MRIcoil 704 positioned to expose one or more fastener attachment points712. The user may then secure the MRI coil 704 to the coil holder 702 byattaching fasteners through the fastener openings 708, 710 of the cover706 to fastener attachment points 712 upon the coil holder 702. Anynumber of fastener openings 708, 710 and fastener attachment points 712can be included the head coil system 700 to accommodate a variety ofoff-the-shelf MRI coils, such that the coil holder 702 and cover 706provide a “universal” attachment system for a number of styles and/orbrands of off-the-shelf MRI coils. In other implementations, rather thanincluding fastener openings 708, 710 in the cover 706 and fastenerattachment points 712 upon the coil holder 702, the cover 706 maymateably engage with the coil holder 702. For example, upon positioningthe MRI coil 704 within the coil holder 702, the cover 706 may be slidinto mating grooves and snapped into place, securing the MRI coil 704.In another example, latches or clips formed into one of the coil holder702 and the cover 706 may mate to opposing connection points on theother of the coil holder 702 and the cover 706. Rather than the cover706, in certain embodiments, two or more attachment bands or sectionsmay releasably attach to the coil holder 702 (e.g., in a mannerdescribed above in relation to the cover 706), securing the MRI coil 704in place.

The head coil system 700, in certain embodiments, includes openings thatprovide access for neurosurgical instruments, such as an opening 714. Auser can adjust the openings to align the openings with a desiredtrajectory. Due to the open structure of the head coil system 700, whilea patient is positioned within the head coil system 700, a surgical teamhas access to a wide variety of trajectories for performingneurosurgical operations, such as a trajectory at or near a side toforehead region of the patient's head, a trajectory at a side of thepatient's head, or a trajectory at the top of the patient's head. Thecomponents of the head coil system 700 are easily released toincorporate different MRI coils.

After the user has achieved a desired alignment and positioned thepatient within the MRI bore with the head coil system 700, the user canconnect the head coil system 700 to a cable to energize the MRI coil704. Further, the user can drape the patient and attach probeintroduction equipment, such as a miniframe or low profile skull anchorand guide. Due to a smooth inner surface of the head coil system 700,surgical draping of the patient is simplified.

The procedures and routines described herein can be embodied as asystem, method or computer program product, and can be executed via oneor more dedicated circuits or programmed processors. Accordingly, thedescriptions provided herein may take the form of exclusively hardware,exclusively software executed on hardware (including firmware, residentsoftware, micro-code, etc.), or through a combination of dedicatedhardware components and general processors that are configured byspecific algorithms and process codes. Hardware components are referredto as a “circuit,” “module,” “unit,” “device,” or “system.” Executablecode that is executed by hardware is embodied on a tangible memorydevice, such as a computer program product. Examples include CDs, DVDs,flash drives, hard disk units, ROMs, RAMs and other memory devices.

FIG. 11 illustrates an exemplary processing system 1100, and illustratesexample hardware found in a controller or computing system (such as apersonal computer, i.e., a laptop or desktop computer, which can embodya workstation according to this disclosure) for implementing and/orexecuting the processes, algorithms and/or methods described in thisdisclosure. The processing system 1100 in accordance with thisdisclosure can be implemented in one or more the components shown inFIG. 1. One or more processing systems can be provided to collectivelyand/or cooperatively implement the processes and algorithms discussedherein.

As shown in FIG. 11, the processing system 1100 in accordance with thisdisclosure can be implemented using a microprocessor 1102 or itsequivalent, such as a central processing unit (CPU) and/or at least oneapplication specific processor ASP (not shown). The microprocessor 1102is a circuit that utilizes a computer readable storage medium 1104, suchas a memory circuit (e.g., ROM, EPROM, EEPROM, flash memory, staticmemory, DRAM, SDRAM, and their equivalents), configured to control themicroprocessor 1102 to perform and/or control the processes and systemsof this disclosure. Other storage mediums can be controlled via acontroller, such as a disk controller 1106, which can controls a harddisk drive or optical disk drive.

The microprocessor 1102 or aspects thereof, in alternateimplementations, can include or exclusively include a logic device foraugmenting or fully implementing this disclosure. Such a logic deviceincludes, but is not limited to, an application-specific integratedcircuit (ASIC), a field programmable gate array (FPGA), a generic-arrayof logic (GAL), and their equivalents. The microprocessor 1102 can be aseparate device or a single processing mechanism. Further, thisdisclosure can benefit from parallel processing capabilities of amulti-cored CPU.

In another aspect, results of processing in accordance with thisdisclosure can be displayed via a display controller 1108 to a displaydevice (e.g., monitor) 1110. The display controller 1108 preferablyincludes at least one graphic processing unit, which can be provided bya number of graphics processing cores, for improved computationalefficiency. Additionally, an I/O (input/output) interface 1112 isprovided for inputting signals and/or data from microphones, speakers,cameras, a mouse, a keyboard, a touch-based display or pad interface,etc., which can be connected to the I/O interface as a peripheral 1114.For example, a keyboard or a pointing device for controlling parametersof the various processes and algorithms of this disclosure can beconnected to the I/O interface 1112 to provide additional functionalityand configuration options, or control display characteristics. An audioprocessor 1122 may be used to process signals obtained from I/O devicessuch as a microphone, or to generate signals to I/O devices such as aspeaker. Moreover, the display device 1110 can be provided with atouch-sensitive interface for providing a command/instruction interface.

The above-noted components can be coupled to a network 1116, such as theInternet or a local intranet, via a network interface 1118 for thetransmission or reception of data, including controllable parameters. Acentral BUS 1120 is provided to connect the above hardware componentstogether and provides at least one path for digital communication therebetween.

The workstation shown in FIG. 1 can be implemented using one or moreprocessing systems in accordance with that shown in FIG. 11. Forexample, the workstation can provide control signals to peripheraldevices attached to the I/O interface 1112, such as actuators 1124 todrive probe positioning and actuation equipment. The workstation, incertain embodiments, can communicate with additional computing systems,such as an imaging unit 1126 and/or an MRI unit 1128, via the I/Ointerface 1112.

One or more processors can be utilized to implement any functions and/oralgorithms described herein, unless explicitly stated otherwise. Also,the equipment rack and the interface platform each include hardwaresimilar to that shown in FIG. 11, with appropriate changes to controlspecific hardware thereof.

Reference has been made to flowchart illustrations and block diagrams ofmethods, systems and computer program products according toimplementations of this disclosure. Aspects thereof are implemented bycomputer program instructions. These computer program instructions maybe provided to a processor of a general purpose computer, specialpurpose computer, or other programmable data processing apparatus toproduce a machine, such that the instructions, which execute via theprocessor of the computer or other programmable data processingapparatus, create means for implementing the functions/acts specified inthe flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in acomputer-readable medium that can direct a computer or otherprogrammable data processing apparatus to function in a particularmanner, such that the instructions stored in the computer-readablemedium produce an article of manufacture including instruction meanswhich implement the function/act specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer orother programmable data processing apparatus to cause a series ofoperational steps to be performed on the computer or other programmableapparatus to produce a computer implemented process such that theinstructions which execute on the computer or other programmableapparatus provide processes for implementing the functions/actsspecified in the flowchart and/or block diagram block or blocks.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made without departingfrom the spirit and scope of this disclosure. For example, preferableresults may be achieved if the steps of the disclosed techniques wereperformed in a different sequence, if components in the disclosedsystems were combined in a different manner, or if the components werereplaced or supplemented by other components. The functions, processesand algorithms described herein may be performed in hardware or softwareexecuted by hardware, including computer processors and/or programmablecircuits configured to execute program code and/or computer instructionsto execute the functions, processes and algorithms described herein.Additionally, certain embodiments may be performed on modules orhardware not identical to those described. Accordingly, otherimplementations are within the scope that may be claimed.

1. A system for introducing neurosurgical instruments into a skull of apatient, comprising: a low profile skull anchor device comprisingattachment means to attach to an area of a skull of a patient, whereinthe low profile skull anchor device comprises a central opening at leastsixty millimeters in diameter for providing access to an entry formed inthe skull of the patient, and the attachment means provides a mountingheight of the low profile skull anchor device of 30 millimeters or lessfrom a surface of the skull of the patient; and a removable guide stemcomprising a locking means for detachably connecting the guide stem tothe low profile skull anchor device, an access means for access to atleast a portion of the entry, wherein the access means is positionedabove the entry formed in the skull of the patient, a trajectoryalignment means that adjusts at least one of a pivot alignment and arotation alignment of the means for access, and at least one trajectorylocking means for locking at least one of the pivot alignment and therotation alignment at a current trajectory.
 2. The system of claim 1,further comprising: an introduction means for inserting a neurosurgicalinstrument, wherein the introduction means comprises a proximal openingand a distal opening, and the introduction means is configured forinsertion in the access means; and a height locking means for locking aheight of the introduction means.
 3. The system of claim 2, wherein theintroduction means comprises a plurality of connection points for matingwith the height locking means.
 4. The system of claim 3, wherein eachconsecutive pair of connection points of the plurality of connectionpoints is separated by a precise distance to enable selection of aparticular height of a plurality of heights.
 5. The system of claim 2,further comprising: a second introduction means for introduction ofanother neurosurgical instrument, wherein a diameter of the distalopening of the second introduction means is smaller than the diameter ofthe distal opening of the introduction means.
 6. The system of claim 5,wherein the second introduction means is configured for insertion withinthe introduction means.
 7. The system of claim 1, further comprising: asecond access means having a smaller diameter opening than the accessmeans, wherein the access means and the second access means areconfigured to be interchangeably connected to the low profile skullanchor device.
 8. The system of claim 7, wherein a shape of the openingof the second access means is different from a shape of an opening ofthe access means.